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The Accell Family of products are intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The products are indicated for use as bone graft extenders in the spine, extremities and pelvis, or as bone void fillers in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

Accell DBM family of products are used for orthopaedic bone grafting procedures. They are osteoconductive human allogenic demineralized bone filling materials for use as fillers for gaps or voids that are not intrinsic to the stability of the bony structure.

Accell DBM family of products are products that are manufactured using human donor demineralized bone and may contain up to 70% poloxamer reverse phase medium carrier (RPM). The demineralized bone is derived from human ground, cortical allograft bone. Poloxamer RPM is an inactive product ingredient that is utilized as a containing agent for the demineralized bone and provides appropriate product handling characteristics for the products.

The products of the Accell DBM family are comprised of the same DBM and RPM components as found in DynaGraft II Gel, FDA cleared under 510(k) number K040419 and Connexus cleared under 510(k)'s K050690 and K052098. In addition, the Accell DBM family of products may contain up to a maximum of 70% of RPM carrier. This is the concentration of RPM already cleared in DynaGraft II gel.

Acceptance Criteria and Device Performance Study for IsoTis Accell DBM Family of Products (K061880)

This submission for the IsoTis Accell DBM Family of Products focuses on demonstrating substantial equivalence to predicate devices, primarily through material characterization and animal studies, rather than clinical efficacy against a specific set of performance criteria for human use.

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not outline specific numerical acceptance criteria for device performance. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices primarily through:

• Material Characterization: Ensuring the chemical composition, pH, and physical characteristics of the carrier (poloxamer RPM granules) are consistent with previously cleared products.
• Resorption Studies: Demonstrating suitable resorption rates of both the carrier and the DBM in animal models, comparable to the predicate.
• Osteoinductivity Potential: Verifying that each lot of DBM exhibits osteoinductive potential using an in vitro assay correlated to an athymic rat assay.
• Viral Inactivation: Confirming the processing methods effectively inactivate a panel of viruses.
• Safety and Performance in Animal Models: Demonstrating no safety or performance issues in animal studies (critical size defects, spinal fusion) compared to the predicate.

Given this, a table of acceptance criteria and reported device performance would look like this:

2. Sample Size for Test Set and Data Provenance

The provided document does not specify exact sample sizes for each animal study conducted for the Accell DBM family of products. It mentions:

• Carrier Resorption: "A resorption study has been performed to examine the rate and extent of carrier elimination in male adult rats." (No sample size provided)
• DBM Resorption: "Resorption of the DBM was demonstrated during rabbit animal studies." (No sample size provided)
• Specific Performance Studies: "These studies included rabbit tibial critical size defects and rabbit spinal fusion studies." (No sample size provided)

The data provenance is prospective animal studies conducted in rabbits and rats. There is no indication of country of origin for the data; typically, such studies would be conducted in the country of device manufacture or where the research facilities are located.

The document also references "Several animal studies were performed on both Connexus and DynaGraft II Gel and were submitted as part of their original 510(k) submissions (K050690 and K040419)." This suggests reliance on previously submitted data for predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This submission relies on animal models and laboratory testing (in vitro), not human clinical data with expert-established ground truth. Therefore, there were no human experts used to establish ground truth for a test set in the traditional sense involving clinical outcomes. The "ground truth" for the animal studies would be the physiological and histological observations made by veterinarians, pharmacologists, and histopathologists during the animal experiments, but their specific number and qualifications are not detailed.

For the in vitro osteoinductive potential assay, the validation to the athymic rat model serves as the ground truth correlation, established through laboratory methods rather than expert clinical consensus.

4. Adjudication Method for the Test Set

The concept of an adjudication method (e.g., 2+1, 3+1) is not applicable here as the studies are animal and in vitro based, not human clinical trials requiring consensus on clinical endpoints. The interpretation of animal study results would typically be done by the research team involved (e.g., veterinary pathologists, histologists) following standard scientific protocols.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and AI assistance is being evaluated for its impact on reader performance. This device is a bone void filler/graft extender, not a diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. This is not a software algorithm or AI device that operates independently. The "device" is a physical material (Demineralized Bone Matrix with a carrier).

7. Type of Ground Truth Used

The ground truth used was:

• Animal Outcomes/Histopathology: For resorption studies (in rats and rabbits) and safety/performance in animal models (tibial critical size defects, spinal fusion in rabbits). This involves observation of tissue remodeling, graft integration, and absence of adverse reactions.
• In Vitro Assay Correlation: For osteoinductive potential, where an in vitro cell culture assay was validated to correlate with an athymic rat osteoinductive potential assay.
• Laboratory Characterization: For chemical composition, pH, and physical characteristics of the carrier, confirmed through analytical testing.
• Viral Inactivation Assays: For demonstrating the efficacy of processing methods against a panel of viruses.

8. Sample Size for the Training Set

The concept of a "training set" in the context of machine learning or AI is not applicable to this submission. The device is a medical material, and its development and testing involve traditional biological and material science studies, not AI model training. Therefore, there is no training set as typically defined for AI/ML products.

9. How the Ground Truth for the Training Set Was Established

As there is no training set in the AI/ML sense, this question is not applicable. The "ground truth" for the various performance aspects of the material (as described in point 7) was established through established scientific methodologies in animal research, in vitro assays, and chemical characterization.

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OrthoBlast® It DBM Paste and Putty are bone filling materials indicated for augmentation or reconstructive treatment of alveolar ridge. This includes:

• Filling of defects after root resection, apicoectomy and cystectomy ・
• Filling of extraction sockets to enhance preservation of the alveolar ridge -
• Elevation of maxillary sinus floor -

OrthoBlast® II DBM Paste and Putty is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier, cancellous chips from the same donor, and then formulated to a paste or puttylike consistency.
OrthoBlast® II DBM Paste and Putty are osteoconductive and osteoinductive bone filling material. The osteoinductive potential is demonstrated in athymic mouse model.

This document is a 510(k) summary for a medical device called OrthoBlast II DBM Paste and Putty, seeking clearance from the FDA. It is not a study report detailing acceptance criteria or device performance based on a study, but rather a regulatory submission for market clearance.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not available in the provided text.

Here's why and what information is available:

• Nature of the Document: This is a 510(k) "Premarket Notification." The purpose of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. It's not a clinical trial report that establishes new performance metrics through a study against predefined acceptance criteria.
• "Performance Data" Section (Section 7): This section states: "Product safety and effectiveness is adequately supported by the substantial equivalence information, materials data, and animal test results provided in this Premarket Notification."
  • This indicates that "performance" in this context refers to demonstrating equivalence and safety through existing data, material characterization, and animal studies, not necessarily human clinical trials with statistical acceptance criteria.
  • It also states "The osteoinductive potential is demonstrated in athymic mouse model." This is an animal study, not a human clinical study.

What can be extracted from the provided text is:

1. Device Name and Intended Use:

• Proprietary Name: OrthoBlast® II Demineralized Bone Matrix Paste and Putty
• Intended Use: Bone filling materials indicated for augmentation or reconstructive treatment of alveolar ridge. This includes:
  • Filling of defects after root resection, apicoectomy and cystectomy
  • Filling of extraction sockets to enhance preservation of the alveolar ridge
  • Elevation of maxillary sinus floor

2. Predicate Device:

• DynaGraft II Dental (Demineralized Bone Matrix) [K043573]

3. Basis for Equivalence (Instead of Acceptance Criteria):

The device is considered "substantially equivalent" based on:

• Utilizing ground, human donor cortical demineralized bone.
• Utilizing an inactive poloxamer reverse phase carrier (RPM).
• Having the same indications for use.
• Being provided sterile.
• Intended for single patient use.

Differences noted for context (though not acceptance criteria):

• Predicate device (DynaGraft II) contains more demineralized bone by weight and volume and less synthetic carrier.
• OrthoBlast II incorporates the same donor's cancellous tissue in particulate form, while DynaGraft II does not.

In summary, the provided text does not contain the information required to fill out the table and answer the specific questions about acceptance criteria and a study proving device meets acceptance criteria, as it is a regulatory submission for substantial equivalence rather than a detailed study report.

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Accell Connexus™ DBM Putty is a bone filling material indicated for augmentation or reconstructive treatment of alveolar ridge. This includes:

• Filling of defects after root resection, apicoectomy and cystectomy -
• Filling of extraction sockets to enhance preservation of the alveolar ridge -
• Elevation of maxillary sinus floor -
• Treatment of periodontal defects -

Accell Connexus™ DBM Putty is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier and formulated to a paste or putty-like consistency.

Accell Connexus DBM Putty is osteoconductive and osteoinductive bone filling material. The osteoinductive potential is demonstrated in athymic mouse model.

The provided text is a 510(k) Premarket Notification for a medical device, Accell Connexus DBM Putty. It does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a diagnostic AI/ML device would.

This document describes a medical device (bone graft material) and seeks clearance based on "substantial equivalence" to a predicate device. For such devices, performance is typically demonstrated through material data, animal studies, and comparison to existing products, rather than the kind of AI/ML performance metrics (like sensitivity, specificity, F1-score, or ROC AUC) that would have acceptance criteria and be proven through a clinical study with detailed ground truth, expert adjudication, and statistical analysis as implied by your questions.

Therefore, I cannot provide the requested information in the format of your questions, as the input document does not contain it.

Here's a breakdown of why each of your requested points cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: No such criteria or performance metrics (like sensitivity, specificity, accuracy) are mentioned. The document relies on substantial equivalence.
2. Sample size used for the test set and the data provenance: No test set in the diagnostic sense is mentioned. Clinical studies with sample sizes are not discussed for performance evaluation in this context.
3. Number of experts used to establish the ground truth... and their qualifications: Ground truth in the context of diagnostic performance (e.g., image interpretation) is not applicable here.
4. Adjudication method... for the test set: Not applicable as there is no test set for diagnostic performance evaluation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: No MRMC study or comparison of human readers with/without AI assistance is mentioned. The device is a bone putty, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; the device is a physical bone graft material, not an algorithm.
7. The type of ground truth used: For a device based on substantial equivalence, the "ground truth" revolves around its material properties, biocompatibility, and intended use matching those of the predicate device, often supported by animal studies for osteoinductivity. The text states "The osteoinductive potential is demonstrated in athymic mouse model," which is a form of pre-clinical "ground truth" for one property.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires training data.
9. How the ground truth for the training set was established: Not applicable.

What the document does state about performance:

• "Accell Connexus DBM Putty is osteoconductive and osteoinductive bone filling material."
• "The osteoinductive potential is demonstrated in athymic mouse model." (This is the closest to a performance study mentioned).
• "Product safety and effectiveness is adequately supported by the substantial equivalence information, materials data, and animal test results provided in this Premarket Notification."

In summary, this document is for a traditional medical device submitting a 510(k) for substantial equivalence, not for an AI/ML diagnostic device with performance characterized by detailed statistical metrics against a ground truth established by experts.

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OsSatura™ Dental is a bone filling augmentation material for used for augmentation or reconstructive treatment of alveolar ridge. This includes, filling of defects after root resection, apicoectomy and cystectomy, filling of extraction sockets to enhance preservation of the alveolar ridge and elevation of maxillary sinus floor.

OsSatura™ Dental is a synthetic, osteoconductive bone void filler, which consists of a biphasic ceramic (e.g., hydroxyapatite/tri-calcium phosphate) scaffold. The interconnected and open porous structure of OsSatura™ Dental is similar in structure to human cancellous bone. OsSatura™ Dental is available as irregular shaped chips of size 1 - 2 mm.

The provided text is a 510(k) summary for a medical device, OsSatura™ Dental. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full efficacy study with specified acceptance criteria in the way a clinical trial for a new drug or novel device might.

Therefore, the document does not contain the detailed information requested regarding specific acceptance criteria, a study that proves the device meets those criteria, or the methodology of such a study.

Here's an explanation of what an ideal response would look like if the information were available, and why it's not present in this document:

Why the requested information isn't here:

• 510(k) Process: The 510(k) pathway (Premarket Notification) is for devices that are "substantially equivalent" to an existing legally marketed device (a predicate). The focus is on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness profiles as the predicate. It generally does not require new clinical efficacy studies with predefined acceptance criteria and statistical power calculations like a PMA (Premarket Approval) application would for a novel, high-risk device.
• "Testing" Section: The "Testing" section {1} states:
  • "Pre-clinical animal data demonstrate that OsSatura™ Dental chips support bone ingrowth into a variety of bony defects."
  • "Biocompatibility, extensive bench and animal testing using OsSatura Dental have successfully been performed to confirm that the device is degraded and resorbed over time and allow bone ingrowth."
  • It also mentions compliance with ASTM standards (F1185-88 and F1088-87) and FDA guidance documents on bone void fillers.
  • It references the long history of safe clinical use of the materials (calcium-based ceramics) and the predicate devices.
• Lack of Specifics: While "testing" was done, the document does not provide:
  • A table of specific quantitative acceptance criteria (e.g., "bone ingrowth percentage must be > X%")
  • The raw performance data from these tests
  • Details on sample sizes for these preclinical/animal studies
  • Information about expert adjudication of results, ground truth methodology, or how a "test set" was defined for performance evaluation in the clinical sense.

If this were a different type of submission (e.g., a PMA or a more involved clinical study), the requested information would be structured as follows:

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The actual document does not provide such a table because it's a 510(k) summary, not a clinical trial report with specific quantifiable acceptance criteria for a primary endpoint.)

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not specified for a clinical performance evaluation in this document. The testing mentioned is preclinical (animal) and bench testing.
• Data Provenance:
  • Preclinical Animal Data: The document mentions "Pre-clinical animal data" {1}. Specific species, number of animals, and origin are not provided.
  • Bench Testing: The document mentions "extensive bench... testing" {1}. Specifics are not provided.
  • Clinical Data: The submission relies on the "long history of safe clinical use for hydroxyapatite and tri-calcium phosphate products" and the safety record of the predicate devices. No new clinical study data with a defined "test set" is presented for OsSatura™ Dental in this summary.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

• Not applicable as no specific clinical "test set" with expert-adjudicated ground truth is described in this document for the OsSatura™ Dental product itself. The preclinical and bench testing would involve researchers and scientists evaluating the results, but not in the context of expert consensus for ground truth on patient outcomes in a clinical trial.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. No clinical "test set" requiring expert adjudication is described in this document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a synthetic bone graft material, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a physical biomaterial, not a standalone algorithm.

7. The type of ground truth used:

• For the preclinical/animal studies and bench testing, the "ground truth" would be established through direct observation, histology, material science analysis, and quantitative measurements of bone growth, degradation, and mechanical properties. This is distinct from, say, pathology or outcomes data in a human clinical trial.
• The overall "ground truth" for regulatory clearance under a 510(k) is primarily the substantial equivalence to legally marketed predicate devices, which already have an established safety and effectiveness profile based on their own testing and clinical use.

8. The sample size for the training set:

• Not applicable. This document describes a medical device (bone graft material), not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable for the same reason as #8.

In summary, the provided 510(k) document is a regulatory submission for a device demonstrating substantial equivalence, not a detailed clinical study report. Therefore, it lacks the specific, quantifiable performance acceptance criteria and detailed study methodologies that would be found in such a report. The "proof" for this device's safety and effectiveness relies on its similarity to existing, legally marketed devices and successful preclinical and bench testing.

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The Open Bore Syringe is intended for use as a piston syringe for delivery of allograft, autograft or synthetic bone graft materials to an orthopedic surgical site. In addition it is designed to facilitate premixing of bone graft materials with autologous blood, plasma, platelet rich plasma, bone marrow aspirate as deemed necessary by the clinical use requirements.

The Open Bore Syringe is a standard piston syringe. It consists of a syringe barrel, piston and plunger. The distal end of the barrel is threaded to enable connection to three different adapters while without an attachment, the open end allows for filling of the bone graft material. Three distinct tips enable connection to a standard female Luer or dispensing through a tapered nozzle or extended tapered nozzle, and can be used depending on the viscosity of the bone graft material. A cap is available to seal the end of the barrel, enclosing the syringe contents. The piston/plunger assembly is used to expel from, or facilitate collection into the barrel.

This 510(k) summary is for the IsoTis OrthoBiologics Open Bore Syringe. Due to its nature as a medical device (a piston syringe), the "study" described focuses on equivalence to predicate devices and adherence to recognized standards, rather than a clinical trial with human subjects and specific AI performance metrics. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.

Here's an analysis of the provided information, addressing the relevant points:

Device: IsoTis OrthoBiologics Open Bore Syringe
Device Type: Medical Device (Piston Syringe)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. For physical device testing against standards like ISO 7886-1, the sample size would typically be determined by the standard itself or internal quality control procedures, but it's not reported in this summary.
• Data Provenance: Not applicable in the context of clinical data. The data refers to engineering and biocompatibility testing results.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable. For this type of medical device (a piston syringe), "ground truth" as it relates to clinical diagnosis or AI output is not relevant. The performance evaluation is based on objective measurements against engineering standards and material properties, overseen by internal quality control and regulatory review, not expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers or in complex diagnostic scenarios, which do not apply to the physical testing of a syringe.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is designed to assess the effectiveness of an AI system, often in comparison to human readers. This device is a manual piston syringe and does not involve AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. This device is purely mechanical and has no algorithm or AI component.

7. The Type of Ground Truth Used

• Engineering Standards and Material Specifications: The "ground truth" for this device's performance is established by recognized international standards (ISO 7886-1), biocompatibility requirements, and the functional characteristics of predicate devices, rather than clinical outcomes or diagnostic accuracy.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this device does not involve machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set, this question is not relevant.

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OsSatura™ BCP (Biphasic Calcium Phosphate) is bone void filler intended only for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. OsSatura™ BCP is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

OsSatura™ BCP is a synthetic, osteoconductive bone void filler, which consists of a biphasic ceramic (e.g., hydroxyapatite/tri-calcium phosphate) scaffold. The interconnected and open porous structure of OsSatura™ BCP is similar in structure to human cancellous bone. OsSatura™ BCP is available as irregular-shaped chips of different sizes.

The provided document, K030131 for OsSatura™ BCP Bone Void Filler, describes a pre-market notification (510(k)) submission to the FDA. The information focuses on showing substantial equivalence to previously approved predicate devices rather than presenting a study with specific acceptance criteria and performance metrics for the device itself in the way that would typically be done for a novel AI/software device.

Therefore, many of the requested elements for describing acceptance criteria and a study proving those criteria are not applicable to this type of document and device. This 510(k) submission relies on:

• Similarity of design, materials, and function to already-approved predicate devices.
• Existing safety and biocompatibility data for calcium phosphates.
• General pre-clinical animal data demonstrating bone ingrowth and resorption, without specific quantitative acceptance criteria reported in this summary.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific numerical targets or quantitative acceptance criteria (e.g., "resorption must be X% by Y weeks," or "bone ingrowth must be Z% of void volume"). Instead, it states that the device "meets requirements" or "confirmed by testing."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document mentions "pre-clinical animal data" and "extensive bench and animal testing" but does not detail the number of animals or specific test samples used.
• Data Provenance: Pre-clinical animal data and bench testing. Country of origin not specified, but likely within the Netherlands (sponsor's location) or a collaborating institution. Data is prospective in the context of these specific tests for the OsSatura™ BCP device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Not Applicable. The ground truth for this type of device, which is a physical bone void filler, is typically established by laboratory measurements (e.g., chemical composition analysis, porosity measurement, degradation rates) and histological evaluation in animal models (e.g., presence and quality of bone ingrowth, evidence of resorption) performed by qualified scientists and veterinary pathologists. There is no mention of "experts" establishing a "ground truth" for a "test set" in the context of human interpretation, which would be relevant for AI/imaging devices.

4. Adjudication Method for the Test Set

• Not Applicable. As there are no human experts "reading" or classifying outcomes in a way that requires adjudication for a physical device like a bone void filler, this is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This device is a physical bone void filler, not an AI or imaging diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This device is a physical bone void filler, not an algorithm.

7. The Type of Ground Truth Used

• Laboratory measurements and histological/imaging analysis in animal models. This includes:
  • Chemical composition analysis: To confirm HA/TCP ratios and purity.
  • Physical properties testing: Porosity, pore size, mechanical strength.
  • Biocompatibility assays: In vitro and in vivo.
  • Histological examination of animal tissue: After implantation, to assess bone ingrowth, integration, and material resorption.

8. The Sample Size for the Training Set

• Not Applicable. As this is a physical medical device, there is no "training set" in the computational or AI sense. The development of the device would involve iterative design and testing, but not a formally defined "training set" for an algorithm.

9. How the Ground Truth for the Training Set was Established

• Not Applicable. See point 8.

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SynPlug™ is a cylindrical plug intended for intramedullary occlusion during cemented hip and shoulder arthroplasty.

The proposed SynPlug™ cement restrictor is identical in intended use and fundamental scientific technology to the parent Shuttle Stop® cement restrictor that was cleared for marketing by FDA on May 4, 2000 (K000587). Design changes were made to prevent cement leakage and migration, increase pressure resistance, and improve the ease of handling of the cement restrictor. These design modifications are limited to the following:

• Adoption of a cylindrical shape for the proposed SynPlug
• Elimination of sidewall slots and addition of five flanges
• Increase in the rigidity of the proposed device
• Expansion of the number of available sizes for the proposed device to 13, designed to fit intramedullary canal diameters of 9 to 21 mm
  This submission also contains a description of instrumentation sets that have been developed to facilitate the selection of cement restrictor size by assessment of the intramedullary canal diameter and provide correct insertion of the cement restrictor. The SynPlug Instrumentation Set consists of 14 measuring probes for the measurement of canal diameters from 9 to 21 mm, two insertion rods, and a sterilization tray for holding the instruments during sterilization. The Shuttle Stop Instrumentation Set is identical to the SynPlug Instrumentation Set with the exception that only five measuring probes are provided to correspond with the four sizes of Shuttle Stop and a probe measuring the maximum intramedullary canal diameter for which the largest size Shuttle Stop can be used, 8 to 20 mm.

I am sorry, but the provided text does not contain the information required to populate the requested table and answer the questions. The document is a 510(k) summary for a medical device called SynPlug™, which is a cement restrictor. It describes the device, its intended use, and states that it is substantially equivalent to a predicate device.

However, it explicitly states:

• "The differences between the proposed and parent devices are minor and do not raise new issues of safety or effectiveness."
• "These design modifications were validated according to IsoTis' Design Control Procedures, in compliance with the design control procedure requirements of the Quality Systems Regulations as specified in 21 CFR 820.30."

This indicates that the submission relies on design control validation and substantial equivalence claims rather than reporting on a specific study that tested the device against explicit acceptance criteria with performance metrics, ground truth, or expert involvement as described in your prompt.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics for the SynPlug™ are listed.
2. Sample size used for the test set and the data provenance: No test set data is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is mentioned.
4. Adjudication method: Not applicable as no test set or ground truth is described.
5. MRMC comparative effectiveness study results: No such study is mentioned.
6. Standalone performance results: No standalone performance metrics are provided.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: No training set is mentioned for an AI/algorithm.
9. How the ground truth for the training set was established: Not applicable.

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